MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title : midterm follow up in patients with reduction ascending aortoplasty the reduction ascending aortoplasty in patients with an aortic ectasia/dilatation is a common procedure during concomitant cardiac operations.The aim of the follow up study was to evaluate the possibility of re-dilatation and its complications.From january 1998 to 2010, a total of 124 patients (85 male and 39 female; mean age: 66.6 ± 12 years) with ectasia of the ascending aorta who had no further indication for an aortic replacement, underwent reduction ascending aortoplasty associated with dilatation and ectasia of the ascending aorta.From 2011 to 2012 the patients were asked to return for a follow-up echocardiography at the (b)(6) hospital.The mean preoperative diameter of the ascending aorta was 4.2 ± 0.6 cm.The patients risk profile was moderate (mean ef 51% ± 11%; euroscore 4.2 ± 2.1).The reduction ascending aortoplasty consisted of the direct resection of an oval section of the anterior wall of the ascending aorta.The aortotomy was then adjusted in 2 layers with prolene 4-0 suture material.Reported complications included secondary hemorrhage at the aortoplasty suture line (n-4) which required surgical intervention and progression of the aortic dilatation (n-4).It was concluded that the reduction ascending aortoplasty is a safe and effective treatment option in patients with dilated ascending aorta (<50 mm) or significant contraindications for aortic replacement.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151
• MDR Report Key: 7635945
• MDR Text Key: 112366404
• Report Number: 2210968-2018-73769
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention